There’s been a flurry of legislative activity on Capitol Hill and at state houses around the country aimed at improving access to contraception. But there are still deep divides on the best way to achieve that access.

At the federal level, there are two competing bills that address access to contraceptives.

The first – the Allowing Greater Access to Safe and Effective Contraceptive Act ( S. 1438 ) – introduced in May by Sen. Cory Gardner (R-Colo.) and Sen. Kelly Ayotte (R-N.H.), would incentivize manufacturers of “routine-use contraceptives” to file an application with the Food and Drug Administration to switch their products from prescription to over the counter (OTC). The bill would allow for priority review for these products and waive the usual FDA filing fee.

The legislation would also repeal the Affordable Care Act’s restriction on the use of health, medical, and flexible savings accounts to purchase OTC drugs without a prescription.

Despite the fact that the bill is aimed at encouraging the switch of contraceptives to OTC products, it’s been criticized by some reproductive health advocates for not adequately addressing the potential for increased costs if women purchase OTC contraceptives not covered by insurance.

Senate Democrats responded with their own birth control legislation. The Affordability Is Access Act ( S. 1532 ), introduced in June by Sen. Patty Murray (D-Wash.), aims to build on the no-cost coverage for contraception in the Affordable Care Act by ensuring that if the FDA approves oral contraceptives for OTC use, they will be covered without cost sharing even though they are not prescription products.

Affordability at issue

The American Congress of Obstetricians and Gynecologists is backing Sen. Murray’s bill.

In an interview, Dr. Mark S. DeFrancesco, ACOG president, said he is pleased to see proposals from both sides of the aisle emerge on this topic because ACOG has long supported the concept of OTC sale of oral contraceptives. But the GOP-backed proposal does not address the issue of copays and insurance coverage, said Dr. DeFrancesco, who is a managing partner at Westwood Women’s Health in Waterbury, Conn.

“An unintended consequence could be, ironically, that it may decrease access for women because if contraceptives are reclassified as nonformulary drugs by going over the counter, can insurance companies say they’re not going to cover them as they don’t cover aspirin, for instance?” Dr. DeFrancesco said. “That’s our concern: that well-intended legislation could have a backfire effect.”

Missed opportunity for screening?

Not everyone favors moving contraceptives over the counter. Dr. W. David Hager, who practices at Baptist Health Medical Group Women’s Care in Lexington, Ky., expressed concern that providing OTC access to contraceptives would hinder the physician-patient relationship and impact screening efforts.

“One of the big advantages for me as a practicing ob.gyn. is to have face-to-face conversations, to be able to discuss risks and benefits, and to counsel young patients about the choices that they are making, to make sure they are making educated, informed choices,” Dr. Hager said.

A shift to OTC access for contraceptives could potentially decrease the uptake of human papillomavirus (HPV) vaccination, said Dr. Hager, who in the early 2000s served on the FDA’s Advisory Committee for Reproductive Health Drugs.

“We’re already at less than 50% implementation with Gardasil, and this may further decrease that,” he said. “It may delay Pap test screening and HPV screening if women choose after age 21 to just purchase over-the-counter contraceptives. It may delay well-woman screening, where women come in just for a wellness exam. And, in my opinion, it eliminates the potential for discussion of any contraindications to birth control pills. Granted, those are not many, but there are some patients who are not ideal candidates for oral contraceptives. I think it potentially takes a cohort of the highest-risk women and removes them from that potential screening and counseling session.”

Dr. DeFrancesco said he knows from experience that patients will come to see their ob.gyn. regularly just because it’s the right thing to do.

“There could be a small percentage of people who say ‘now I really don’t have to see the doctor, because that’s the only reason I was going,’ ” he said. “The good news about more people being covered with insurance is that at least people are more empowered to go to the physician’s office or the provider’s office to get care.”

States take the lead

While the federal bills are drawing attention, they are no closer to becoming law. But it’s a different story at the state level.

In Washington, the D.C. Council approved a bill that requires health plans to authorize the dispensing of up to 12 months of a woman’s prescription for contraception at one time. The legislation was signed by D.C. Mayor Muriel Bowser (D) in June but won’t apply to health plans until Jan. 1, 2017.

In Oregon, lawmakers enacted similar legislation ( House Bill 3343 ) that requires health insurers to pay for a 12-month supply of the birth control pill, patch, or the ring at one time. The new law goes into effect on Jan. 1, 2016. The Oregon Medical Association, which supported the bill, said that the ability for women to get a 12-month supply of birth control at one time would ease administrative burdens for medical office staff, patients, and pharmacists by lessening refill requests.

In July, Oregon Gov. Kate Brown (D) also approved a related law House Bill 2879 , which permits pharmacists in Oregon to prescribe hormonal contraceptive patches and self-administered oral contraceptives. The State Board of Pharmacy will develop rules for how the new system will work, but the law specifies that pharmacists must complete a training program for prescribing hormonal contraceptives, and it requires patients to use a self-screening risk assessment tool before they can receive a prescription. For minors, the law requires evidence of a previous prescription for hormonal contraceptives. The law goes into effect on Jan. 1, 2016.

In California, expanded pharmacist scope of practice legislation known as SB 493 was signed into law by Gov. Jerry Brown (D) on Oct. 1, 2013, and it became effective on Jan. 1, 2014. One of the law’s provisions enables pharmacists to furnish self-administered contraceptives according to standards developed by the California State Board of Pharmacy and the Medical Board of California.

However, this provision is still in the administrative rule-making process, said Sarah McBane, Pharm.D., president of the California Pharmacists Association. According to the original legislation, patients will be required to use a self-screening tool to identify risk factors.

dbrunk@frontlinemedcom.com

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